NCT02033070

Brief Summary

The purpose of this study is to provide a tool for physicians to compare outcome data related to the use of the HALO Ablation Systems. This study is a single-center patient registry which will contribute to a framework for treatment and follow-up of patients with Barrett's Esophagus.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

January 8, 2014

Last Update Submit

January 9, 2014

Conditions

Barrett's Esophagus

Keywords

RFA

Outcome Measures

Primary Outcomes (1)

  • Endoscopic clearance rate for Barrett's Esophagus

    Outcome measure is assessed at Month 12

Secondary Outcomes (1)

  • Histological clearance rate for intestinal metaplasia

    Biopsy taken at 12 months

Other Outcomes (1)

  • Histological clearance rate for dysplasia

    Biopsy taken at 12 months to determine effectiveness

Study Arms (1)

Non-Dysplastic IM, LGD, HGD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients presenting with esophageal intestinal metaplasia (IM), including the pathological subclasses of non-dysplastic IM, low-grade dysplasia (LGD) and high-grade dysplasia (HGD)

You may qualify if:

  • candidate for ablation of Barrett's Esophagus with the HALO Ablation System (Prospective)
  • received an ablation with the HALO Ablation System to treat Barrett's Esophagus (Retrospective)
  • candidate agrees to proposed follow-up schedule of yearly surveillance following treatment
  • signs consent

You may not qualify if:

  • has not been diagnosed with Barrett's Esophagus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center

Kenner, Louisiana, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum from Biopsy

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Virendra Joshi, MD

    Oshsner Clinic Foundation and Medical Center-Kenner

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Virendra Joshi, MD

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 10, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2015

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

US(1)